Methylene blue (ProvayBlue) is a thiazine dye that's FDA approved to treat methemoglobinemia, a serious condition where red blood cells can’t deliver oxygen properly to the body. It's also used off-label for conditions like malaria, shock, and as a diagnostic aid for imaging. The medication is typically given intravenously (IV) by a healthcare professional to adults and children who are in the hospital. The dosage is based on body weight. Side effects include headache, diarrhea, and low potassium or magnesium levels in the blood.
Hemoglobin is a protein that carries oxygen throughout the body. Sometimes, when the body is exposed to certain medications or chemicals, it can create a different form called methemoglobin. Methemoglobin can’t carry oxygen, and too much of it leads to a serious condition called methemoglobinemia.
Methylene blue (ProvayBlue) is a thiazine dye. It works to treat methemoglobinemia by changing methemoglobin back to hemoglobin, so it can carry oxygen to the body.
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
These side effects were reported in at least 2% of people:
Contact your healthcare provider immediately if you experience any of the following.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Incidence not known
Agitation
bluish-colored lips, fingernails, or palms
confusion
dark urine
difficulty breathing
difficulty swallowing
dizziness or lightheadedness
fast heartbeat
headache
hives or welts, itching, or skin rash
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
overactive reflexes
pale skin
poor coordination
rapid heart rate
redness of the skin
restlessness
shivering
sweating
talking or acting with excitement you cannot control
tightness in the chest
trembling or shaking
twitching
unusual bleeding or bruising
unusual tiredness or weakness
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
Abdominal or stomach pain
bigger, dilated, or enlarged pupils (black part of the eye)
blue staining of the urine, skin, and mucous membranes
bluish-colored lips, fingernails, or palms
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
confusion
dark urine
difficulty breathing
dizziness or lightheadedness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fear
headache
increased sensitivity of the eyes to light
pale skin
rapid heart rate
rapid shallow breathing
shakiness in the legs, arms, hands, or feet
tightness in the chest
unusual bleeding or bruising
unusual tiredness or weakness
vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Change in taste
changes in skin color
feeling hot or cold
increased sweating
loss of taste
muscle or joint pain
pain at the infusion site
pain in the arms or legs
Less common
Back pain
bruising
chills
general feeling of discomfort or illness
large, flat, blue or purplish patches in the skin
loss of appetite
muscle aches and pains
trouble sleeping
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The standard dosage of methylene blue (ProvayBlue) to treat methemoglobinemia is 1 mg/kg of your body weight. It’s typically given as a one-time IV infusion in a hospital, lasting 5 to 30 minutes. But if your methemoglobin level remains above 30% or you're still experiencing methemoglobinemia symptoms (e.g., shortness of breath, fast heart rate, weakness), your care team will consider repeating the dose.
No. Methylene blue (ProvayBlue) isn't taken orally (by mouth); it's given only as an injection into a vein (IV). But methylene blue it's an active ingredient in some oral medications like Hyophen and Uribel Tabs. These medications are used to help with urinary irritation, inflammation, and pain.
Methylene blue (ProvayBlue) is generally safe when used the right way. But like any medication, it has risks and side effects so it might not be suitable for everyone. For example, it can cause serotonin syndrome, a potentially life-threatening condition. The risk is higher if you're taking other medications that raise serotonin levels, such as antidepressants like SSRIs or SNRIs, certain opioids, or migraine medications like triptans. Share a complete list of your medications with your care team to make sure they are safe for you to use.
No. Methylene blue (ProvayBlue) doesn't kill cancer cells. But it can be used off-label as a diagnostic aid to help find cancer cells on imaging tests.
Methylene blue (ProvayBlue) might not be the safest choice in pregnancy or breastfeeding. The medication can cause harm to an unborn baby during pregnancy. It's also not known whether the medication passes into breastmilk. To avoid potential serious side effects, it's recommended that you stop breastfeeding during treatment and up to 8 days after receiving methylene blue (ProvayBlue). To make sure methylene blue (ProvayBlue) is safe for you, let your care team know if you're pregnant or breastfeeding.
Methylene blue (ProvayBlue) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Some people who received methylene blue (ProvayBlue) developed a rare but serious condition called serotonin syndrome. This condition happens where there's too much serotonin in the brain. Your risk is higher if you take methylene blue (ProvayBlue) with other medications that can raise your serotonin levels, such as certain antidepressants, mental health medications, pain medications, and migraine medications. Tell your care team about all the medications you take before starting methylene blue (ProvayBlue). Symptoms of serotonin syndrome include fast heart rate, sweating, muscle stiffness or spasms, fever, and confusion. Let your care know right away if you have any of these symptoms.
Severe allergic reactions to methylene blue (ProvayBlue) are possible, including life-threatening reactions like facial swelling, shock, and anaphylaxis. Let your care team know right away if you notice hives, swelling of the lips or tongue, or difficulty breathing after receiving this medication.
Methylene blue (ProvayBlue) can cause hemolytic anemia, which is when your red blood cells are broken down. This can happen 1 or more days after receiving the injection, and some people have had to get red blood cell transfusions to treat it. Your healthcare team will monitor your blood cell counts before and during treatment. Let them know if you have symptoms such as tiredness, dizziness, and weakness.
Methylene blue (ProvayBlue) can cause confusion, dizziness, and vision problems. Avoid driving or doing anything dangerous until these side effects go away. Talk to your prescriber if you have concerns.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Methylene blue (ProvayBlue) will not be safe for you to take.